Tetradecafluorohexane

Long-term toxicity to fish

Administrative data

Endpoint:

fish early-life stage toxicity

Type of information:

(Q)SAR

Adequacy of study:

key study

Study period:

November 2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

Deviations:

not applicable

Remarks:

QSAR

Principles of method if other than guideline:

The chronic toxicity to fish was determined using a validated QSAR for the Mechanism of Action (MechoA) in question (MechoA 1.1, i.e. non-polar narcosis) (3). The QSAR is based on validated data for a training set of 26 chemicals derived from 14 to 32-day test on fish, for which the concentrations of the test item had been determined by chemical analyses over the test period.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Tetradecafluorohexane

EC Number:

206-585-0

EC Name:

Tetradecafluorohexane

Cas Number:

355-42-0

Molecular formula:

C6F14

IUPAC Name:

tetradecafluorohexane

Test material form:

liquid

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Results from the following species were used in the regression:

Danio rerio, Pimephales promelas, Oryzias latipes, Leuciscus idus, Jordanella floridae, Cyprinus carpio

Study design

Test type:

flow-through

Water media type:

not specified

Total exposure duration:

28 d

Remarks on exposure duration:

Only results from a test duration of 14* to 32 days were included. The median study duration was 28 days.

Test conditions

Test temperature:

The temperatures varied from approximately 21 to 27 °C depending on the fish species used to construct the algorithm.

pH:

Test results were taken from studies with measured pHs between 6.0 - 8.5

Results and discussion

Effect concentrations

Key result

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

ca. 0.11 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

not specified

Remarks on result:

ChV (chronic value, QSAR)

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The test item falls within the applicability domain of the model and can therefore be considered a reliably prediction for chronic toxicity (28d-NOEC) to fish. Therefore, this endpoint value can be considered valid for use in risk
assessment and classification and labelling.
The 28d-NOEC of the test item to fish was predicted as 0.11 mg/L.
95% confidence interval (α = 0.05): 0.087 – 0.14 mg/L.
The QPRF can be found as a separate document (8).
The QMRF can be found as a separate document (9).

Executive summary:

Introduction.

A QSAR model model was used to calculate the chronic toxicity to fish of the test item 1,1,1,2,2,3,3,4,4,5,5,6,6,6-TETRADECAFLUOROHEXANE. This QSAR model has been validated to be compliant with the OECD recommendations for QSAR modeling (OECD, 2004) (1) and predicts the endpoint value which would be expected when testing the substance under experimental conditions in a laboratory following Guideline for Testing of Chemicals No. 210, "Fish, Early-life Stage Toxicity Test" (2). The criterion predicted was the NOEC (No Observed Effect Concentration), a tested concentration which is observed to cause no effect on growth or reproducibility within a period of 28 days.

Methods.

The chronic toxicity to fish was determined using a validated QSAR for the Mechanism of Action (MechoA) in question (MechoA 1.1, i.e. non-polar narcosis) (3). The QSAR is based on validated data for a training set of 26 chemicals derived from 14 to 32-day test on fish, for which the concentrations of the test item had been determined

by chemical analyses over the test period.

Results.

The result below is the chronic toxicity value anticipated during a 28-day NOEC study on fish. The 28-day

NOEC is calculated as follows:

Time (d)	NOEC (mg test item.L^-1)	95% confidence limits (mg test item.L^-1)
28	0.11	0.087 – 0.14